Oral Health and Fundamental of Care Program

NCT06755411 | Completed

• 1 other identifier: CE078/2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Oral health significantly impacts daily life, affecting communication, nutrition, emotional expression, self-esteem, and overall quality of life. Poor oral health is associated with conditions ranging from caries and periodontal disease to systemic issues such as diabetes, cardiovascular disorders, and increased mortality. Background and Rationale: Oral frailty, a concept originating in Japan in 2013, highlights the deterioration of oral function due to aging, potentially leading to malnutrition and systemic health impacts. The 2017 Global Burden of Disease Study emphasized oral health as an ongoing global challenge, identifying caries, severe periodontitis, and edentulism as prevalent issues. Preventable oral diseases contribute significantly to health disparities and systemic illnesses. Aims: Primary: To evaluate the impact of an educational intervention to implement evidence-based guidelines for oral health care in adult inpatients. Secondary: To assess the concordance between different assessment tools and the improvement in knowledge of healthcare workers following training. Methods: Study Design: A before-and-after interventional study comparing pre- and post-educational intervention implementation cohorts. Setting: Medical Department, Maggiore della Carità Hospital, Novara, Italy. Eligibility: Adults aged ≥18 years admitted for inpatient care who consent to participate. Outcomes: Improvements in oral health outcomes as assessed by the OHAT tool and secondary metrics such as knowledge improvement in healthcare staff. Intervention: Training Sessions: Healthcare workers receive education on oral health guidelines, including practical and simulation-based activities. Implementation: Adoption of evidence-based practices for oral health care. Evaluation Phases: Phase 1 (Baseline): Assessment of oral health in patients using OHAT and a structured evaluation protocol. Phase 2 (Intervention): Educational sessions for healthcare workers. Phase 3 (Post-Implementation): Follow-up assessments using the same tools and methods as Phase 1. Data Analysis: Statistical methods include descriptive analysis, repeated measures models, and pre-post intervention comparisons. A significance level of 0.05 will be applied. Sample Size: A minimum of 48 participants (24 per cohort) is required, based on a hypothesised effect size of 0.5 with 80% power and a significance level of 0.05. Ethical Considerations: The protocol will be submitted for ethical approval. Data will be anonymised and handled per EU Regulation 2016/679 (GDPR). Dissemination of Results: Findings will be published in peer-reviewed journals and presented at conferences, maintaining participant confidentiality.

Conditions

Oral Hygiene, Oral Health; Oral Cavity; Nursing Care; Nursing Education

Keywords

oral hygiene; oral health; fundamental of care; nursing care; nursing education

Outcome Measures

Primary Outcomes (1)

• Variation of OHAT score related to educational intervention and timing T0, T5 and T100 (discharge)

  The Oral Health Assessment Tool (OHAT) uses a Likert scale ranging from 0 (very healthy) to 2 (very unhealthy) for each item, with a total of 8 items assessed. The maximum score is 16, and higher scores indicate worse oral health conditions. The OHAT average score differences in the pre-post-intervention phases, assessing if the educational intervention produces an effect of reducing the progression of oral cavity deterioration. Regarding the analysis of mouth conditions, any changes between admission and discharge were assessed with the OHAT tool. Because the data are correlated (evaluated at separate times) and classified into three groups (good, sufficient, and inadequate) Bhapkar's test was applied. The same assessment was done assuming that just the difference between T5 and T100 is reported, excluding the first evaluation upon admission, because it is influenced by oral hygiene practices carried out at home or in other setting.

  T0= ADMISSION; T5= DAY-5 (and every 5-days until discharge); T=100 (discharge)

Study Arms (2)

Pre-intervention group

NO INTERVENTION

The pre-intervention group was recruited between May and June 2023. At admission, every 5 days, and at discharge, an expert (dentists and/or dental hygienists) inspected the patient's oral cavity. The specialist personnel of the Department of Dentistry recorded data and observations on the proper documentation approved by the local ethics committee, combining the collection of socio-demographic data with the completion of the OHAT scale through its Italian validated version and the Internal Protocol of the Surgical Department of Dentistry (standard protocol). The expert panel assessed the selected patients during the following time frame: T0a (at admission); T0d (at discharge); T0i 1, 2, 3,… (intermediate) at five-day intervals until discharge, always at the same ideal time (about 9.00 am). Data collection required approximately 15 minutes per patient each time.

OHFCP2

ACTIVE COMPARATOR

The intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity. A training course was developed for nurses and social health professionals. Lecture sessions on the most recent literature were held, as well as practical learning training sessions in high fidelity simulation, which included the assessment, preservation, and care of the oral and dental health.The intervention was administered to small groups consisting of 5-6 participants. An in-patient room situation with three possible scenarios and corresponding simulation manikins was set up: a person with a healthy oral cavity, a person with prosthesis, and an edentulous old person. After implementing the educational intervention, a new data collection phase began in the same hospital department during December replicating the same patient recruitment and evaluation process.

Other: OHFCP2

Interventions

OHFCP2 OTHER

The proposed intervention consists of a two-phase approach for implementing guidelines and evidence-based recommendations: educating healthcare professionals and enhancing clinical activity.

OHFCP2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who met the requirements for the study should have been at least 18 years old, be admitted on a regular schedule, and be able to understand and give informed consent for the study. Patients assigned, even temporarily, to other inpatient wards were not eligible
• Only patients admitted to Internal General Medicine Ward at Maggiore della Carità Hospital, Novara, a 640-bed university hospital in northern Italy.

You may not qualify if:

• Patients unable to understand and consent, with critical conditions preventing oral cavity assessment (e.g., presence of non-removable non-invasive ventilatory support devices, transient disorientation, unwillingness to participate) were excluded. Patients had the right to withdraw their participation agreement at any point during the study.

Sponsors & Collaborators

• Alberto Dal Molin: lead
• Azienda Ospedaliero Universitaria Maggiore della Carita: collaborator

Study Sites (1)

AOU Maggiore della Carità

Novara, Italy, 28100, Italy

Location

Related Publications (45)

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Related Links

• CDC Oral Health.
• Oral health for adults in care homes
• Oral health: local authorities and partners
• Oral health promotion in the community
• RNAO. Best practice guidelines: oral health supporting adults
• World Health Organization. Health topics/Oral health

Study Officials

• Chiara Gallione, PhD, MSN, RN

  AOU Maggiore della Carità di Novara

  PRINCIPAL INVESTIGATOR

• Cristian Vairo, PhD st, MSN, RN

  AOU Maggiore della Carità di Novara

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Associate Professor

Model Details: Study design: the effectiveness of an evidence-based practice educational program to improve the quality of oral care has been evaluated in a before-and-after quasi-experimental study. The study adhered to The TREND statement guidelines, which provide a 22-item checklist designed to ensure consistent reporting of nonrandomized controlled trials. This statement, which is complementary to the widely recognized CONSORT statement for randomized controlled trials, was utilized to guide the study's methodology (Des Jarlais, Lyles, Crepaz, \& TREND Group, 2004).

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: May 16, 2023
• Primary Completion: December 11, 2023
• Study Completion: July 9, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)